BEUDAMED
    14 results · 17ms · Sources: EU EUDAMED, US FDA

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    SLIDEX STREPTO-KIT

    FDA 510(k)
    FDA Class 1 ·Microbiology

    Nexxis OR

    FDA UDI
    Barco NV·05415334002388·NEXXIS SYSTEM X670 CM

    Rampart One Lumbar Interbody Fusion Device

    FDA UDI
    SPINEOLOGY INC.·M7404905020·Rampart One Screw

    ENDOSKELETON® TAS

    FDA UDI
    TITAN SPINE, LLC·00191375052081·Double Bend Inserter Tray, Base

    Arthrex®

    FDA UDI
    ARTHREX, INC.·00888867316379·LOW PROFILE CORTICAL SCW, TI, 5.0x20M

    NexGen® Complete Knee Solution

    FDA UDI
    Zimmer, Inc.·00889024202269·

    MODEL N742 SUNGLASSES W/ACRYLIC NIGHT DRIVER LENS

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    RESPIRATION/HEART RATE MONITOR MODEL 9500/9550

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    QUICKSITE LV

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code OJX·January 9, 2013

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·AV-REDWOOD CITY·Product code MGB·November 22, 2010

    DEPUY DUOFIX MBT TRAY SZ 5

    FDA Adverse Event
    Injury ·DEPUY IRELAND-9616671·Product code NJL·July 1, 2014

    AQUABILITI AQUASTAT 0.9% Sodium Chloride Injection syringe, USP, 5mL in 12mL, REF 2T0805; and 3mL in 12mL, REF 2T0807, intermediate cartons containing 100 syringes, shipping cases containing 400 syringes, Rx, Sterile.

    FDA Enforcement
    Class II ·Ongoing·MRP, LLC dba Aquabiliti·February 28, 2024

    smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·March 27, 2024

    paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·October 2, 2024